BILL ANALYSIS Ó ----------------------------------------------------------------- |SENATE RULES COMMITTEE | AB 599| |Office of Senate Floor Analyses | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ----------------------------------------------------------------- THIRD READING Bill No: AB 599 Author: Bonilla (D) Amended: 8/24/15 in Senate Vote: 21 SENATE BUS, PROF. & ECON. DEV. COMMITTEE: 9-0, 6/8/15 AYES: Hill, Bates, Berryhill, Block, Galgiani, Hernandez, Jackson, Mendoza, Wieckowski SENATE APPROPRIATIONS COMMITTEE: 6-0, 6/22/15 AYES: Lara, Bates, Beall, Hill, Leyva, Mendoza NO VOTE RECORDED: Nielsen ASSEMBLY FLOOR: 77-0, 4/30/15 (Consent) - See last page for vote SUBJECT: Clinical laboratories: cytotechnologists SOURCE: California Association of Cytotechnologists California Society of Pathologists DIGEST: This bill expands the scope of practice for a licensed cytotechnologist by authorizing the performance of all tests and procedures pertaining to cytology under the supervision of a qualified laboratory director, as specified. Senate Floor Amendments of 8/24/15 restate existing federal law regarding lab certification, and require that a cytotechnologist AB 599 Page 2 work under a lab director who is a physician certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. ANALYSIS: Existing law: 1) Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel, including cytotechnologists, by the California Department of Public Health (DPH). (Business and Professions Code (BPC) §§ 1200-1327) 2) Requires DPH to adopt regulations identifying the modification, education, training, and examination necessary whenever it determines that the specialties or subspecialties authorized under an existing license category should be modified. (BPC § 1208 (a)) 3) Defines cytological slides as cellular materials submitted for preliminary cytologic examination. (BPC § 1211.5) 4) Prohibits a person from performing examinations of cytological slides unless he or she has either a cytotechnologist license issued by the DPH or a valid physician's and surgeon's certificate. (BPC § 1270) 5) Establishes conditions that laboratories must meet for certification to perform testing on human specimens under Clinical Laboratory Improvement Amendments. (Title 42, Code of Federal Regulations (CFR) § 493.1) 6) Requires that all cytology slide preparations to be evaluated on the premises of a laboratory certified to conduct testing in the subspecialty of cytology and requires the laboratories to establish written policies and procedures for staining, error controls, workload limits, slide AB 599 Page 3 retention, automated and semi-automated screening devices, and documentation. (42 CFR § 493.1274) 7) Requires a cytotechnologist to document: a) The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed. b) For each 24-hour period, the total number of slides examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer. c) The number of hours spent examining slides in each 24-hour period. (42 CFR § 493.1485) 8) Requires a lab to establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. (42 CFR 493.1274 (c)) 9) Requires a lab to establish and follow written policies and procedures that ensure that the technical supervisor establishes a maximum workload limit for each individual who performs primary screening, and reassesses each individual's workload limit at least every six months and adjust when necessary. (42 CFR 493.1274 (d)) 10)Requires the DPH to establish standards for the evaluation of cytological slides and for reporting the adequacy of cytological slides. (BPC § 1272.4) This bill: 1) Authorizes a licensed cytotechnologist to perform all tests and procedures pertaining to cytology, including, but not AB 599 Page 4 limited to, microscopic and nonmicroscopic methodologies and tests and procedures that utilize molecular or genetic methodologies that are performed on cytologic specimens related to infectious disease or cancer diagnosis, under the overall operation and administration of a laboratory director. 2) Requires that a cytotechnologist work under a lab director who is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. 3) Requires that any tests or procedures performed by a licensed cytotechnologist be performed in a licensed clinical laboratory certified in the subspecialty of diagnostic cytology. Background Cytotechnology and Cytotechnologists. Cytotechnology is the microscopic study of cells for evidence of disease, such as cancer. Many other conditions, including viral and bacterial infections, also are identified using cytological techniques. The field is perhaps best known for the Pap test, an evaluation of cells from the uterine cervix, but cytotechnology techniques can identify precancerous or cancer cells in virtually any area of the body. Cytotechnologists are licensed by Laboratory Field Services, a division of the DPH. To qualify for licensure, an applicant must have a baccalaureate degree from an accredited college or university, with 20 semester hours of biological science, eight semester hours of chemistry, and three semester hours of math; complete a 12-month accredited cytotechnology program; and pass the American Society for Clinical Pathology Board of Registry examination in cytology. There are approximately 800 licensed cytotechnologists in California. Cytotechnologists typically work in hospital laboratories, universities, and private laboratories and perform processing and microscopic review of various sample types to identify pathologic conditions, particularly cancer. The primary cytotechnologist workload is review of cervical smears (Pap AB 599 Page 5 test) to detect cervical cancer. Cytotechnologists work under the supervision of a laboratory director. Scope of Practice. Current law limits the type of tests a cytotechnologist can perform because the underlying statute authorizing their scope refers to "slides." New technological advances have resulted in non-slide based tests and techniques, which are currently prohibited. Statutes related to the scope of practice for a cytotechnologist have not been updated since 1991. According to the author, statutory limitations on practice are causing cytotechnologists to leave the state. "California has only two approved cytotechnology training programs, University of California and Loma Linda University (LLU), and both of them have pared back substantially their programs in recent years. In fact, LLU currently has no enrolled students. Moreover, it is our understanding that many of these program's recent graduates are now following their colleagues in seeking careers outside of California. This workforce pipeline setback is compounded by a recruitment problem faced by California laboratories in that the flawed state law makes it very difficult to license laboratory professionals trained in other states." While current law requires the DPH to adopt regulations whenever it determines that the specialties or subspecialties authorized under an existing license category should be modified, the author states that an effort to update cytotechnologist regulations has been stalled for more than four years. Additionally, it is unclear whether regulations would be sufficient to change a cytotechnologist's duties because the authorizing statute refers specifically to "slides." FISCAL EFFECT: Appropriation: No Fiscal Com.:YesLocal: No According to the Senate Appropriations Committee: One-time costs of about $120,000 per year for two years to develop and adopt regulations regarding training standards and the scope of practice for cytotechnologists by the DPH (Clinical Laboratory Improvement Fund). Those costs will be covered by licensing fee revenues. AB 599 Page 6 Minor ongoing costs to license cytotechnologists and enforce the revised standards by the DPH (Clinical Laboratory Improvement Fund). SUPPORT: (Verified8/20/15) California Association of Cytotechnologists (co-source) California Society of Pathologists (co-source) American Society for Clinical Pathology American Society of Cytopathology California Clinical Laboratory Association California Hospital Association Numerous individuals OPPOSITION: (Verified8/20/15) Engineers and Scientists of California ARGUMENTS IN SUPPORT: The California Association of Cytotechnologists write, "The current regulations [governing the practice of cytotechnologists] were adopted in 1991. Since that time, dramatic advances in medicine and indeed cytopathology have taken place. HPV testing, which accompanies Pap smear testing has become the standard of care for cervical cancer surveillance. Fluorescent in situ hybridization (FISH) and other molecular prognostic laboratory tests are rapidly developing. The cytotechnology programs across the country have also changed their curriculum to teach these new technologies. Unfortunately, these outdated regulations have crippled the cytotechnology community in California, leading to a loss of talented educated cytotechnologists." The California Hospital Association writes, "[Existing law] is exacerbating an existing laboratory personnel workforce shortage as many cytotechnologists trained in California are moving out of state where they can practice to the full extent of their education and training. In addition, in order to comply with this antiquated state statute, laboratories are sending tissues out of state to be tested. Valuable health care personnel and AB 599 Page 7 services are being driven out of California, even though cytotechnologist's education and training in California schools includes these testing techniques." ARGUMENTS IN OPPOSITION: The Engineers and Scientists of California express concerns that "AB 599 may have unintended negative patient impacts. While some recently licensed cytotechnologists may have the requisite education to have this expanded scope of practice, the bill does not contain any requirements that would ensure that the proper education and training has occurred?. At the very least, the bill should be amended to apply to only those who meet the 2013 education standards." ASSEMBLY FLOOR: 77-0, 4/30/15 AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea, Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Atkins NO VOTE RECORDED: Campos, Chávez, Gomez Prepared by:Sarah Huchel / B., P. & E.D. / (916) 651-4104 8/25/15 15:25:42 **** END ****